- lead a high-performing QA operations team of direct reports, aligned to support plant goals and schedules,
- train and develop a team to fully utilize the workforce and eliminate one-deeps,
- manage and improve site process in alignment with site needs,
- support the development of objectives for Quality Operations and manage the execution of strategic objectives to achieve site goals,
- client interactions – Formal change and non-conformance notifications, QA representative on joint working teams supporting investigations, technology transfers, and other client-facing activities,
- prompt and effective escalation of major GMP issues,
- participate in communities of practice related to quality operations, deviations, and product disposition,
- deliver presentations to senior management, clients, and regulatory bodies during audits.
- Master’s degree in a Science or related field with a minimum of 2+ years of experience in chemical/pharmaceutical production,
- experience in working with ISO9001 quality management standards,
- 5+ years of experience in the pharmaceutical or biotechnology industry,
- 2+ years of managerial experience,
- 2+ years experience in a Quality Assurance or Quality Control role,
- project management skills and experience,
- knowledge of phase-appropriate quality system and product lifecycle requirements,
- direct experience performing batch disposition activities (raw materials or products),
- hands-on experience with establishing plant QA functions, e.g. batch record review, release, etc.,
- continuous improvement mindset and ability to utilize operational excellence and lean manufacturing tools.
- work in an international environment,
- employment contract,
- development opportunities,
- salary commensurate with your skills.